Background:Clinical Research Associates urgently required to perform clinical trial initiation, monitoring and close out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Study Specific Operating Procedures.
This will include:
• full responsibility for co-ordinating with the ethics committee and research & development committees to set up clinical trial sites and assist less experienced CRA’s;
• locate and assess the suitability of facilities at a study centre;
• training site staff to industry standards;
• monitoring the trial throughout its duration, including visits to the study centres on a regular basis;
• verifying that data entered on to the CRFs is consistent with patient clinical notes (SDV);
• collecting completed CRF pages;
• writing visit reports;
• maintaining contact with centres via phone calls and emails;
• file and collate trial documentation and reports;
• ensure supplies are provided to sites;
• ensure all unused trial supplies are accounted for;
• archive study documentation and correspondence;
• communicate effectively with site personnel, including the Principal Investigator, and management to relay protocol/study deviations and ensure timely implementation of corrective actions.
Additional Information:In addition to:
· perform co-monitoring visits with a CRA I/CTA for training purposes where appropriate.
· resolve queries of CRF data with study site personnel.
· act as mentor for a CRA I/CTA.
